1 Introduction

The international standard for medical laboratory quality and competence, ISO 15189, was significantly updated in December 2022, establishing a new global benchmark for best practices. Although laboratory accreditation currently remains a voluntary quality benchmark within Nigeria’s national policy framework, this revision, ISO 15189:2022, places more emphasis on patient-centered risk management and robust governance to ensure the delivery of accurate, timely, and reliable laboratory results that enhance patient care [1, 2]. Central to this standard is the principle of clear and effective leadership. ISO 15189:2022 places leadership-related responsibilities within its structural and governance requirements. Clause 5 addresses the legal entity, laboratory director, laboratory activities, structure and authority, objectives and policies, and risk management [3]. In this context, the standard is concerned with clearly defined responsibility, authority and accountability for laboratory activities and the management system rather than prescribing professional jurisdiction. Effective QMS implementation requires alignment between top-down leadership commitment and bottom-up operational execution. Leadership provides resources, authorizes quality policies, and establishes accountability, while frontline personnel ensure adherence to standard operating procedures, incident reporting, and internal quality control to safeguard patient safety [2, 4].

It is important to distinguish between professional jurisdiction (who holds the title of “Head of Department” or “Laboratory Director”) and organizational governance (who is accountable for the QMS). ISO 15189:2022 focuses on the latter. In developed health systems, clinical laboratory governance is structured around defined organizational accountability rather than inter-professional territorial disputes. For instance, the Clinical Laboratory Improvement Amendments (CLIA) framework establishes functional qualification pathways for laboratory directors, technical supervisors, and testing personnel in the United States based on test complexity tiers [5]. Similarly, in the United Kingdom, clinical laboratories accredited by the United Kingdom Accreditation Service (UKAS) operate under integrated pathology directorate models where consultant pathologists and registered biomedical scientists function under defined administrative and clinical reporting lines [6].

However, Nigeria presents a unique challenge where the systemic regulatory fragmentation may contribute to complexities in establishing and maintaining stable governance models, with potential implications for laboratory quality and accreditation readiness [7]. A long-standing and often protracted professional dispute between pathologists, regulated by the Medical and Dental Council of Nigeria (MDCN), and medical laboratory scientists, regulated by the Medical Laboratory Science Council of Nigeria (MLSCN), has created a state of regulatory dualism. This conflict is rooted in competing legislative mandates over laboratory oversight and headship [8, 9], and is actively sustained and institutionalized by professional associations, principally the Nigerian Medical Association (NMA) and its sister bodies representing medical practitioners, and the Association of Medical Laboratory Scientists of Nigeria (AMLSN), which regularly mobilize membership dues to prosecute protracted jurisdictional litigations before the National Industrial Court of Nigeria and appellate courts, entrenching operational divides, diagnostic delays, and industrial disharmony [10,11,12,13,14].

Although regulatory dualism may interact with wider systemic constraints including infrastructural deficits, erratic power supply, and resource scarcity, its specific operational influence on laboratory quality compliance requires structured examination. Against this background, regulatory dualism may further complicate compliance with the ISO 15189:2022 standard’s core requirements for leadership, organizational structure, and quality policy. This article explores the historical and legal origins of this regulatory dualism, analyzes the professional rivalry associated with it, and examines its potential implications for the ability of Nigerian laboratories to meet ISO 15189:2022 requirements. By examining the underlying systemic barriers and drawing on comparative perspectives, this review aims to identify practical pathways for resolving governance challenges, with potential implications for patient safety, laboratory quality, and the broader strengthening of Nigeria’s health system.

2 Methods

2.1 Study design

This study was conducted as a structured narrative review using a qualitative thematic synthesis approach to integrate heterogeneous evidence on laboratory governance, professional regulation, quality management systems (QMS), accreditation, and ISO 15189 implementation in Nigeria. A narrative review design was selected because the evidence base comprised empirical studies, legislation, regulations, judicial decisions, policy and technical documents, institutional reports, and selected contextual sources that were not amenable to quantitative meta-analysis. The review was designed and reported in accordance with relevant principles of the Scale for the Assessment of Narrative Review Articles (SANRA) to enhance methodological transparency, scientific reasoning, and reporting quality [15]. A PRISMA-informed process was used to structure literature identification, screening, eligibility assessment, and inclusion.

2.2 Analytical framework

The review was guided by three predefined analytical domains: (i) legislative and historical origins of regulatory dualism affecting laboratory services in Nigeria; (ii) implications of regulatory and organizational arrangements for laboratory governance, QMS, and ISO 15189 implementation; and (iii) comparative experiences and policy strategies for addressing governance and quality-system challenges. Evidence identified through the literature search was mapped to these domains and synthesized to examine relationships among professional regulation, organizational authority, laboratory governance, quality management, accreditation, and risk management.

2.3 Literature search, eligibility criteria and study selection

A comprehensive literature search was conducted for publications and documentary evidence available between January 2000 and August 2026. The final searches were conducted in September 2026. Electronic databases searched included PubMed/MEDLINE, Scopus, Google Scholar, and African Journals Online (AJOL). The search period was selected to capture the historical development of professional regulation and laboratory governance in Nigeria, the emergence of laboratory quality-management and accreditation initiatives, and subsequent developments relevant to ISO 15189:2022. Database searches were supplemented by targeted searches of authoritative grey literature, including legislation and regulations, judicial decisions, official policy and technical documents, accreditation and laboratory-system reports, and publications from relevant national and international organizations.

The search strategy combined Boolean operators across three thematic clusters:

  • Cluster 1 – Laboratory quality and standards: "ISO 15189" OR "Laboratory Quality Management System" OR "LQMS" OR "Accreditation" OR "quality management" OR "Clinical Governance".

  • Cluster 2 – Regulatory and professional context: "Pathologist" OR "Medical Laboratory Scientist" OR "medical laboratory science" OR "interprofessional conflict" OR "Interprofessional rivalry" OR "Regulatory conflict" OR "MDCN" OR "MLSCN" OR "laboratory governance" OR "Health Policy".

  • Cluster 3 – Geographical and contextual terms: "Nigeria" OR "Sub-Saharan Africa" OR "Africa" OR "Low- and Middle-Income Countries" OR "LMIC".

The principal search combined the three clusters using AND, with database-specific syntax and controlled vocabulary where available. Search strategies were adapted to the indexing requirements of each database. Google Scholar was additionally searched to identify relevant publications and grey literature not readily retrieved through bibliographic databases. Reference lists of included sources were manually screened for additional eligible evidence.

Sources were eligible if they: (i) addressed laboratory leadership, organizational governance, professional regulation, or interprofessional relations relevant to medical laboratory services in Nigeria; (ii) examined laboratory QMS, accreditation, ISO 15189 implementation, or laboratory-strengthening programmes in Nigeria; (iii) provided primary documentary evidence concerning the statutory or regulatory framework governing laboratory medicine in Nigeria, including legislation, regulations, official policy documents, or judicial decisions; or (iv) described laboratory quality-improvement or accreditation experiences in other low- and middle-income countries, particularly sub-Saharan African settings, where these provided relevant comparative insight into governance, leadership, QMS implementation, or accreditation.

Eligible evidence comprised peer-reviewed original studies, systematic and narrative reviews, policy and technical documents, institutional reports, legislation, judicial decisions, and other authoritative documentary sources. Sources were excluded if they had no substantive relevance to laboratory governance, professional regulation, QMS, accreditation, or laboratory strengthening; addressed non-human laboratory sectors without relevant implications for medical laboratory services; duplicated previously identified evidence; or consisted solely of opinion or commentary without substantive empirical, legal, documentary, or policy evidence. No study design was excluded solely on methodological grounds because the review required integration of heterogeneous evidence types. Media reports were considered only where necessary to document public events, institutional responses, or the chronology of professional disputes and were not used as primary evidence for legal interpretation or quantitative estimates where authoritative sources were available.

Study selection followed a PRISMA-informed process. A total of 423 records were identified through database and supplementary searches. After removal of 132 duplicates, 291 unique records underwent title and abstract screening. Following exclusion of 166 records, 125 reports were assessed in full text for eligibility. Sixty-nine full-text reports were excluded, leaving a final total of 56 sources, of which 49 were included in the qualitative narrative synthesis and 7 provided foundational, conceptual, and methodological support (Fig. 1).

Fig. 1
Fig. 1
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PRISMA-informed study identification and selection flow diagram illustrating identification, screening, eligibility assessment, and inclusion of evidence for this narrative review of laboratory governance, professional regulation, QMS, and ISO 15189 implementation in Nigeria (January 2000–August 2026)

2.4 Data extraction, evidence appraisal and thematic synthesis

Data were extracted using a standardized framework covering author or issuing institution and year, country and setting, source type and study design, professional and institutional context, principal governance or regulatory issue, laboratory quality or accreditation framework, key findings, implications for ISO 15189 implementation, and evidentiary role. For legislation and judicial decisions, relevant statutory provisions or findings and institutional context were recorded; policy and programme documents were assessed for responsible institution, objectives, implementation mechanisms, and reported outcomes.

The review included heterogeneous evidence types, therefore no meta-analyses were undertaken and no single risk-of-bias instrument was applied across all sources. Credibility was assessed according to source type and purpose. Peer-reviewed studies were considered in relation to design, methodological clarity, setting, and consistency of findings and conclusions. Legislation, regulations, and judicial decisions were treated as primary legal evidence and, where possible, assessed from original documents. Government, regulatory, accreditation, and international-organization documents were treated as authoritative documentary or policy evidence, while institutional reports were assessed for provenance, transparency, and relevance. Media sources were used only as contextual evidence and were not relied upon for legal conclusions, causal claims, or quantitative estimates where primary sources were available.

Evidence was synthesized qualitatively across three predefined domains: (i) legislative and historical origins of regulatory dualism; (ii) implications for laboratory governance, QMS, and ISO 15189 implementation; and (iii) comparative experiences and potential policy strategies. Initial coding identified substantive findings and evidentiary roles, followed by grouping into higher-order themes. Evidence was compared across source types and settings to identify areas of convergence, disagreement, and gaps.

The synthesis distinguished between directly reported findings, conclusions supported by legal or policy interpretation, and plausible mechanisms or implications inferred from the evidence. Inferential claims were appropriately qualified and were not presented as demonstrated causal relationships. This approach prevented heterogeneous evidence from being treated as equivalent and maintained a clear distinction between documented findings and analytical interpretation. Supplementary Table S1 summarizes the 49 sources included in the synthesis by source type, geographical or institutional setting, principal contribution, and evidentiary role.

3 Main text

3.1 Historical and legal background

The governance framework in Nigeria’s laboratory sector is a product of two parallel professional and legislative histories that have resulted in a complex and sometimes overlapping regulatory system.

3.1.1 Evolution of laboratory governance in Nigeria

Pathology in Nigeria dates back to the colonial era, with early histopathology services at Lagos Island General Hospital in 1893 and expansion in the 1960s following the return of foreign-trained pathologists. Medical Laboratory Science (MLS), in contrast, developed later into a structured profession in the 20th century [16, 17]. These paths created two interdependent cadres: pathologists, who provide clinical diagnostic interpretation, and medical laboratory scientists, who conduct laboratory analyses [18]. These roles are complementary but grounded in differing professional orientations, namely clinical oversight and technical operations.

The professionalization of MLS progressed through key legislative milestones, including Decree No. 56 of 1968, culminating in the Medical Laboratory Science Council of Nigeria (MLSCN) Act No. 11 of 2003, which established the MLSCN as the statutory regulator [8, 19]. Concurrently, the medical profession, including the speciality of pathology, has been regulated by the Medical and Dental Council of Nigeria (MDCN), established under the Medical and Dental Practitioners Act (now Cap M8, Laws of the Federation of Nigeria 2004) [9].

3.1.2 Conflicting legislative mandates and governance rationales

The regulatory dualism stems directly from conflicting provisions within the enabling Acts of these two councils, reflecting divergent philosophies regarding laboratory governance (Table 1).

  • The MDCN Rationale – Clinical Oversight: The Medical and Dental Practitioners Act (MDCN Act) empowers the MDCN to make regulations for the “operation of clinical laboratory practice in the field of Pathology” [9]. The governance rationale here is grounded in the concept of “Clinical Responsibility.” Pathologists argue that the laboratory is not merely a technical production unit but a clinical consultation service. From this perspective, leadership must reside with a medically qualified professional who can integrate laboratory data with the patient’s clinical history, manage complex diagnostic dilemmas, and assume legal liability for patient management decisions [18, 20]. This model aligns with the definition of a “Clinical Laboratory” where the end-product is a medical consultation, thereby placing the laboratory under the jurisdiction of the Medical and Dental Council.

  • The MLSCN Rationale – Technical and Operational Autonomy: On the other hand, the Medical Laboratory Science Council of Nigeria Act (MLSCN Act) grants the MLSCN the power to “inspect, regulate and accredit medical laboratories” (both public and private) and explicitly states that “Medical Laboratories whether Government owned or private shall be headed by a Medical Laboratory Scientist with cognate experience” [8]. This position is premised on “Technical Competence.” The rationale is that Scientists possess the specialized technical expertise required to manage the analytical processes, quality control systems, and operational logistics of the modern laboratory. The MLSCN views the laboratory as a distinct technical facility, a “Medical Laboratory”, that requires autonomous management separate from clinical ward rounds [21].

Table 1 Key legislative and judicial provisions relevant to laboratory governance in Nigeria
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3.1.3 The gridlock – judicial ambiguity and implementation challenges

This legislative ambiguity wherein one Act regulates “clinical laboratory practice” and the other regulates “medical laboratories,” has contributed to a persistent regulatory and administrative impasse [12, 13]. The distinction between a “clinical laboratory” and a “medical laboratory” is not clearly defined in law, and the resulting implementation challenges likely reflect broader systemic and administrative constraints rather than a single underlying cause. Although the National Industrial Court of Nigeria (NICN) has issued judgments addressing the statutory scope of medical laboratory scientists and their claims concerning laboratory departmental leadership, these decisions have operated within a wider institutional and legislative environment that includes the governance framework of teaching hospitals [25, 26] (Table 1).

Furthermore, many tertiary institutions provide diagnostic services through specialized “Pathology Departments” rather than a single “Medical Laboratory Department,” making the practical application of statutory headship complex within existing hospital structures [27]. Consequently, administrators face a dilemma between adhering to NICN judgments and maintaining internal clinical governance bylaws [28]. This governance gap persists despite the 2008 Maputo Declaration on Strengthening of Laboratory Systems, which encouraged Member States to develop coherent national laboratory policies and coordination mechanisms, including strengthened leadership structures within Ministries of Health, to improve governance and reduce fragmentation in laboratory services [29, 30]. This lack of a unified legal and policy interpretation shifts the focus from quality improvement to a cycle of litigation.

3.2 The anatomy of a professional rivalry

The historical and legal context of regulatory dualism has fostered long-standing professional tensions between pathologists and medical laboratory scientists [7]. This situation represents a systemic challenge that contributes to industrial disharmony and policy stagnation within the healthcare system [10]. The core areas of dispute include:

  • Headship of Laboratories: Jurisdictional overlaps regarding laboratory leadership remain a prominent point of friction. While medical laboratory scientists assert that headship is a statutory right under the MLSCN Act, pathologists traditionally hold these roles in many tertiary hospitals. This has led to recurring litigation at the National Industrial Court of Nigeria (NICN) [11, 14, 26].

  • Professional Autonomy and Recognition: Medical laboratory scientists advocate for an autonomous professional structure with intra-professional supervision. This often contrasts with traditional healthcare hierarchies that place physicians in overall leadership roles [20, 27, 31].

  • Remuneration and Hierarchy: Disparities in career progression and salary structures, often linked to leadership eligibility, further exacerbate these tensions. Such perception of systemic inequities can undermine the professional collaboration and teamwork essential for the effective implementation of ISO 15189-compliant quality systems [7].

Inter-professional disputes have been associated with industrial actions that can disrupt healthcare delivery, with potential implications for patient care, and this fragmented leadership in medical laboratories may provide a fertile ground for its festering. Furthermore, judicial interventions have often had limited practical impact because they do not fully harmonize the specific professional acts with the broader governance laws of teaching hospitals [28]. This environment highlights the need for a governance framework that prioritizes integrated functionality over professional jurisdiction to support quality imperatives.

3.3 Implications for quality management systems and ISO 15189:2022 implementation

The existing regulatory overlaps may contribute to structural challenges affecting the implementation of quality management systems (QMS) in medical laboratories. Clauses 5.1–5.6 of ISO 15189:2022 address structural and governance requirements, including legal entity, laboratory director, laboratory activities, structure and authority, objectives and policies, and risk management [3]. Together, these requirements emphasize clarity of responsibility, authority and accountability for laboratory activities and the QMS rather than the professional identity of laboratory leaders [3] (Table 2). In the Nigerian context, overlapping professional mandates and institutional governance arrangements may complicate implementation where responsibilities, reporting relationships or decision-making authority are insufficiently aligned [8, 32]. However, the available evidence does not establish that regulatory dualism directly causes QMS failure or poor accreditation outcomes; rather, it supports a plausible governance pathway through which ambiguity or fragmentation of authority could hinder consistent implementation, accountability and risk management [3, 33].

Table 2 Implications of ISO 15189:2022 clause 5 requirements for laboratory governance in Nigeria
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3.4 Systemic consequences and the state of accreditation

The challenges associated with implementing the governance requirements of ISO 15189:2022 should be considered within the broader ecosystem of factors affecting laboratory quality and accreditation in Nigeria [34]. These include infrastructural deficits, unreliable electricity supply, supply-chain constraints, workforce limitations, equipment-related challenges, and inadequate or inconsistent financing. Regulatory dualism may interact with these material and institutional constraints by complicating the allocation of responsibility, coordination of QMS activities, and implementation of quality-improvement initiatives. However, the available evidence does not allow the independent contribution of regulatory dualism to accreditation outcomes to be quantified.

One important implication is the potential difficulty of implementing harmonized Standard Operating Procedures (SOPs) across the laboratory. Where leadership and reporting relationships are unclear, individual departments or professional groups may develop divergent practices, creating inconsistencies in test processes and potentially affecting the reliability and comparability of laboratory results [35]. Resource constraints may further compound these difficulties, as fragmented governance could limit the coordinated use of available personnel, equipment and reagents. Administrative tensions between professional groups may also contribute to fragmented operations and organizational segregation, making communication and coordination more difficult [36]. Such fragmentation can complicate the teamwork required to sustain a functional QMS and the continuous improvement processes required by ISO 15189:2022.

Prolonged jurisdictional disputes and industrial disharmony may also divert institutional attention from quality-improvement priorities. Such disputes can consume managerial attention and institutional resources that would otherwise support activities central to QMS development, including staff training, preventive equipment maintenance, quality improvement initiatives, and participation in external quality assessment programmes [14]. Thus, even where funding or equipment is available, fragmented governance may constrain the coordinated implementation and continuous improvement processes required by ISO 15189:2022.

Formal ISO 15189 accreditation of medical laboratories in Nigeria remains limited. Available official sources report different accreditation counts depending on the accreditation scheme and reporting date: the Nigeria National Accreditation System (NiNAS) currently lists four active medical testing laboratories, while the Medical Laboratory Science Council of Nigeria (MLSCN) reported in January 2025 that nine medical laboratories had received accreditation to ISO 15189:2012 and/or ISO 15189:2022 through its Accreditation Service. The figures reflect different accreditation schemes and reporting periods, but both indicate that formal ISO 15189 accreditation remains limited in Nigeria [37, 38]. Accreditation remains distinct from regulatory inspection and facility registration, and available MLSCN guidance describes accreditation under ISO 15189 as voluntary, while inspection forms part of the regulatory approval process [39].

Donor-supported laboratory-strengthening programmes, including SLMTA and SLIPTA, have contributed to substantial improvements in laboratory quality systems across Africa [35]. However, progression from stepwise quality improvement to formal ISO accreditation requires sustained institutional commitment, technical support and financing. Where quality-improvement activities depend substantially on external programmes, continuity may become more difficult when external support ends. Sustaining accreditation therefore requires integration of QMS activities into routine institutional planning and financing, including recurrent provision for equipment maintenance, proficiency testing, calibration and standardized reagents.

The influence of governance arrangements is unlikely to be uniform across laboratory settings. Private laboratories operating within corporate governance structures and public institutions with clearly defined local reporting arrangements may be better positioned to establish functional QMS structures despite the broader regulatory environment. At the same time, infrastructure, financing, workforce capacity, equipment, electricity supply and supply-chain limitations remain important constraints on laboratory quality improvement. Effective laboratory governance should therefore be considered alongside, rather than in isolation from, these material and systemic determinants of accreditation readiness and sustainability.

3.5 Underlying structural and systemic barriers

The Nigerian laboratory quality environment is shaped by interacting governance, regulatory, policy and institutional factors rather than by regulatory dualism alone [34]. Nigeria already possesses an accreditation infrastructure through NiNAS and the MLSCN Accreditation Service, while national laboratory policies and technical guidance have continued to develop [29, 30, 40,41,42,43]. Nevertheless, historical fragmentation of administrative oversight and the coexistence of professional regulation, facility licensing and accreditation functions may create coordination challenges [8, 44, 45]. The policy challenge is therefore better understood as one of coherence, implementation, coordination and resourcing, rather than an absence of national laboratory guidance or accreditation infrastructure.

A second cluster of barriers concerns legislative ambiguity and inter-professional governance. The separate statutory mandates of the MDCN and MLSCN have left aspects of laboratory practice, professional responsibility and institutional leadership open to competing interpretations [8, 9, 21], while broader alignment among professional regulation, facility oversight, laboratory policy and accreditation remains an outstanding governance issue [17]. Judicial decisions have addressed aspects of professional autonomy and departmental leadership, but their institutional application needs to be understood in relation to the specific orders and circumstances of individual cases [11, 26]. These unresolved interfaces may complicate the establishment of consistently understood organizational responsibilities, although the available evidence does not demonstrate a direct causal relationship between regulatory ambiguity and laboratory quality or accreditation outcomes.

Finally, stakeholder engagement and sustained institutional commitment remain relevant to implementation. Reported concerns surrounding changes to the role of professional councils in educational accreditation illustrate the importance of consultation where regulatory responsibilities intersect with professional training and quality assurance [46]. Similarly, the persistence of unresolved inter-professional and legislative issues despite previous reform efforts suggests a continuing need for coordinated implementation, legislative review and institutional engagement [14, 47,48,49]. Within this broader context, phased accreditation of designated reference laboratories represents a potential policy pathway consistent with stepwise laboratory-strengthening approaches promoted through WHO/AFRO initiatives [50]. Together, these findings suggest that strengthening accreditation readiness in Nigeria will depend on improving coordination across existing regulatory and quality structures while addressing the broader institutional and resource conditions required for sustained QMS implementation (Table 3).

Table 3 Underlying structural and systemic barriers affecting laboratory governance and accreditation in Nigeria
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3.6 Institutional leadership and accreditation experiences in Sub-Saharan Africa

Experiences from other low- and middle-income countries in Sub-Saharan Africa provide useful institutional perspectives on the conditions that support laboratory quality improvement and accreditation. Although these experiences do not establish a direct relationship between national regulatory arrangements and accreditation outcomes, they illustrate the importance of institutional leadership, management commitment, staff engagement and structured QMS implementation in laboratories pursuing accreditation.

Institutional experiences from Ghana and Tanzania illustrate these principles. At the 37 Military Hospital in Ghana, the laboratory’s pursuit of ISO 15189 accreditation occurred in the context of resource constraints, staff attrition and organizational challenges; sustained leadership commitment, staff engagement and resource mobilization were identified as important elements of the accreditation process [51]. At Bugando Medical Centre in Tanzania, structured QMS implementation and management support similarly facilitated progress toward ISO 15189 conformity despite resource limitations [52]. These examples are institutional case experiences that demonstrate how management commitment, defined responsibilities, staff participation and structured quality-improvement processes can support accreditation efforts. Stepwise approaches, including structured mentorship and progressive implementation of quality-system requirements, have also been used in laboratory-strengthening programmes across the region [53, 54].

These institutional experiences demonstrate that accreditation and progressive QMS improvement are achievable in resource-constrained settings when laboratories have sustained management commitment, defined responsibilities, staff engagement and structured quality-improvement processes. In Nigeria, strengthening these institutional conditions alongside improvements in infrastructure, financing, workforce capacity, equipment, supply chains and regulatory coordination may facilitate wider adoption of ISO 15189. Quality-improvement programmes such as SLMTA can provide a structured platform for this process when supported by sustained institutional commitment [53].

3.7 Pathways to resolution and policy recommendations

Addressing Nigeria’s laboratory governance challenges requires coordinated action across legislation, regulation, institutional management, quality management systems (QMS), and accreditation. The evidence indicates a need for clearer delineation of responsibility and accountability while preserving the distinct functions of professional regulation, institutional governance, and conformity assessment. The 2008 Maputo Declaration emphasized coordinated national laboratory-system strengthening through collaboration among governments, laboratories, and supporting partners, including stronger national coordination and laboratory policies [29, 30]. In Nigeria, this supports strengthening existing coordination mechanisms, particularly the National Laboratory Technical Working Group (NLTWG), rather than creating parallel structures [55].

The legislative interface also requires clarification. The separate statutory mandates of the Medical and Dental Council of Nigeria (MDCN) and the Medical Laboratory Science Council of Nigeria (MLSCN) have contributed to areas of overlap in professional practice, responsibility, and institutional oversight [8, 9]. Legislative review could clarify these boundaries and establish more coherent arrangements for organizational laboratory governance while preserving legitimate professional regulatory functions. The Directorate of Medical Laboratory Services within the Federal Ministry of Health and Social Welfare can support national policy coordination, while accreditation should remain a distinct conformity-assessment function under the applicable accreditation mechanism, including the NiNAS Medical Testing Laboratory Accreditation Scheme. Existing national laboratory policies and QMS guidance provide a foundation for this work and should be implemented coherently rather than replaced by a new policy architecture [37,38,39,40].

Several policy pathways follow from these considerations. These include legislative harmonization, strengthening existing national coordination mechanisms, phased accreditation of strategically important laboratories, alignment of facility regulation with QMS and accreditation pathways, and targeted technical collaboration. The options below are author-proposed pathways informed by the available evidence and assessed in terms of rationale, feasibility, resource implications, and potential unintended consequences (Table 4). Implementation would require collaboration among the Federal Ministry of Health and Social Welfare, professional and regulatory bodies, accreditation organizations, educational authorities, and health institutions. The persistence of governance challenges despite previous reform initiatives highlights the importance of sustained implementation and institutional engagement [14, 47,48,49].

Table 4 Policy pathways for strengthening laboratory governance and ISO 15189:2022 implementation in Nigeria
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3.8 Implementation considerations

These pathways should be implemented as a sequenced programme rather than as isolated reforms. In the immediate term, strengthening the NLTWG and establishing an agreed framework for functional responsibilities would provide a practical basis for coordination and clarification of organizational accountability. In the medium term, legislative review, implementation of existing QMS guidance, development of a phased accreditation strategy, and alignment of facility-regulatory benchmarks could address key structural and operational gaps. Longer-term priorities should include legislative reform where substantive overlaps remain, sustainable domestic financing for QMS and accreditation maintenance, and progressive expansion of accreditation as institutional capacity and national accreditation infrastructure develop. International technical and professional partnerships should support this process while progressively transferring expertise and quality-improvement functions to national systems [29, 50].

Collectively, these measures aim to improve coherence among professional regulation, organizational governance, QMS implementation, and accreditation without attributing Nigeria’s laboratory-quality challenges to governance alone. Laboratory performance is also shaped by infrastructure, workforce capacity, financing, equipment, electricity, supply chains, and other health-system factors. The overarching policy objective should therefore be to establish a governance environment in which responsibilities, authority, QMS accountability, and accreditation functions are clearly differentiated but effectively coordinated, while addressing the broader system conditions required for sustainable laboratory quality improvement (Table 3).

4 Limitations of the study

This review has several limitations. First, the heterogeneous nature of the evidence base, which included empirical studies, legal and policy documents, programme reports, institutional case studies and selected contextual sources, required narrative rather than quantitative synthesis and introduces the possibility of interpretative bias. Second, quantitative evidence directly examining relationships between regulatory arrangements, QMS performance and ISO 15189 accreditation outcomes in Nigeria is limited. Consequently, the review identifies associations, patterns and plausible pathways rather than establishing causal relationships between regulatory dualism and accreditation outcomes. Third, evidence concerning broader determinants of accreditation, including infrastructure, electricity supply, financing, workforce capacity, equipment, calibration and supply-chain reliability, was heterogeneous and could not be quantitatively compared. Finally, media reports were used selectively for contextual information concerning public events and professional disputes; where primary legal, policy or institutional sources were available, these were preferred for substantive interpretation.

5 Conclusion

The implementation of ISO 15189:2022 provides an important framework for strengthening the quality and competence of medical laboratories in Nigeria. This review highlights regulatory dualism and fragmented institutional leadership as important governance challenges within a broader landscape that also includes infrastructure, financing, workforce, equipment, electricity supply, supply-chain limitations and other health-system constraints. Clear organizational responsibility, defined authority and effective coordination are important enabling conditions for implementing and sustaining QMS requirements, but accreditation outcomes are shaped by multiple interacting determinants.

Progress toward wider accreditation will require coordinated policy and institutional action, including continued efforts to clarify regulatory responsibilities, strengthen national laboratory coordination, implement existing QMS guidance, develop sustainable financing mechanisms and establish a phased accreditation strategy for priority laboratories. Strengthening organizational accountability while maintaining clear distinctions between professional regulation, institutional governance and independent accreditation could provide a more stable environment for QMS implementation. Within this broader systems approach, regulatory harmonization represents an important policy opportunity for supporting laboratory quality and patient safety in Nigeria.